Device product
2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.
Z-2738-2015
Product summary
- Event
- Event 71936
- Status
- Terminated
- Classification
- Class II
- Quantity
- 108 units
- Official record key
device-enforcement:Z-2738-2015
Official wording
Reason: Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the potential for shallow engagement between the driver and the screw, resulting in an increased likelihood of stripping screw heads intraoperatively. Specifically, the minor diameter of the drive feature is above the specification, potentially reducing the engagement between the driver and the screw head.
Code information: TSL002605
Distribution pattern: NY, OH, CA, SC, NJ, AZ, VA, IN, FL, MN, OK, AR, MO, WI, GA, SD, IA, IL, TX
Derived failure modes
-
Potency or specification failure
out of specification